Guardant360 CDx Gains European Union Certification for Tumor Profiling in Solid Tumors

Peter Fasching, MD

The Guardant360 CDx blood test has received certificationfrom TÜV SÜD Product Service under the European Union’s In Vitro Diagnostic Regulation (IVDR 2017/746) for tumor mutation profiling in patients with solid tumors. The certification also encompasses Guardant360 CDx as a companion diagnostic to identify patients who may benefit from certain targeted therapies for advanced non–small cell lung cancer (NSCLC) and breast cancer.¹

The decision certifies Guardant360 CDx to be used to identify patients with NSCLC who may benefit from therapy with osimertinib (Tagrisso), amivantamab-vmjw (Rybrevant), or sotorasib (Lumakras). The certification also covers Guardant360 CDx to identify patients with advanced breast cancer harboring ESR1 mutations who could benefit from treatment with elacestrant (Orserdu).

“The IVDR certification for the Guardant360 CDx liquid biopsy is a significant milestone for cancer care in the EU [European Union], as the test provides faster access to comprehensive genomic profiling for oncologists and, more importantly, for the patients they treat,” Helmy Eltoukhy, PhD, the chairman and co-chief executive officer of Guardant Health said in a news release. “We are confident that this certification will help accelerate wider adoption of guideline-recommended genomic profiling, pave the way for the development of new targeted therapies, and increase the number of [patients with] advanced cancer who receive potentially life-changing treatments.”

Guardant360 CDx is a comprehensive genomic test that provides comprehensive results from a simple blood draw using ctDNA analysis in 7 days; the test covers all genes recommended by the National Comprehensive Cancer Network. The test enables clinicians to identify somatic mutations in solid tumors and offer personalized treatment options to patients with advanced cancer. Since its inception, Guardant360 CDx has been featured in over 400 peer-reviewed publications, being used by over 12,000 oncologists with more than 500,000 tests performed.

In August 2020, the FDA approved Guardant360 CDx for comprehensive genomic profiling in patients with any solid malignancy. The test was also approved by the agency as a companion diagnostic to detect EGFR mutations in patients with NSCLC who could potentially benefit from osimertinib. The regulatory decision made Guardant360 CDx the first comprehensive genomic profiling liquid biopsy test to be approved by the FDA.²

Under the current iteration of the IVDR, most manufacturers must obtain a conformity assessment and certificate from an accredited company such as TÜV SÜD. The IVDR certification for Guardant360 CDx ensures that it will be broadly accessible across the EU to help oncologists identify patients who are candidates for clinical trials and to match patients with the proper precision therapy to effectively target their disease.¹

“I am pleased that the new IVDR framework provides strict and high quality standards for diagnostic tools, because this will contribute to better standard of care and clinical trial protocols,” said Peter Fasching, MD, professor of obstetrics and gynecology and coordinator of the Breast Cancer Center and the Gynecological Cancer Center at the Comprehensive Cancer Center Erlangen-EMN in Germany, stated in the press release. “Using IVDR-certified liquid biopsy more broadly will allow us to find more biomarkers that can be targeted in the future and gives clinicians confidence that they are using a highly validated tool to select the optimal individualized treatment plan for the patient.”

References

1. Guardant Health receives EU IVDR certification for Guardant360 CDx liquid biopsy for tumor mutation profiling across all solid cancers and companion diagnostic indications. News release. Guardant Health, Inc. May 21, 2024. Accessed May 22, 2024. https://www.biospace.com/article/releases/guardant-health-receives-eu-ivdr-certification-for-guardant360-cdx-liquid-biopsy-for-tumor-mutation-profiling-across-all-solid-cancers-and-companion-diagnostic-indications/?keywords=cancer
2. Guardant Health Guardant360 CDx first FDA-approved liquid biopsy for comprehensive tumor mutation profiling across all solid cancers. News release. Guardant Health, Inc. August 7, 2020. Accessed May 22, 2024. https://www.globenewswire.com/news-release/2020/08/07/2075187/0/en/Guardant-Health-Guardant360-CDx-First-FDA-Approved-Liquid-Biopsy-for-Comprehensive-Tumor-Mutation-Profiling-Across-All-Solid-Cancers.html